Safety and Effectiveness of Azidothymidine (AZT) in HIV-Positive Patients With Hemophilia

• Status: Completed
• Trial end date: 1989-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see if giving azidothymidine (AZT) to HIV-positive patients with hemophilia is safe and if it is effective in lowering HIV levels and boosting the immune system.

HIV infects and inactivates certain blood cells that are part of the body's immune system. The damage to the body's immune system can result in unusual infections and/or unusual forms of cancer. A large percentage of hemophiliacs are HIV-positive and there is a clear risk for the development of AIDS in these patients. AZT may be effective in lowering HIV levels and boosting the immune system but its side effects are not understood in these patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Zidovudine

Criteria

Inclusion Criteria

You may be eligible for this study if you:

• Are HIV-positive.

• Have a bleeding disorder such as hemophilia A or B, a lack of factor VIII (a blood clotting factor), or severe von Willebrand's disease.

• Will be available for follow-up for at least a year.

• Are at least 12 years old (consent of parent or guardian required if under 18).

• Are willing to use an effective method of birth control during the study.

Exclusion Criteria

You will not be eligible for this study if you:

• Have a life-threatening opportunistic (AIDS-related) infection or AIDS-related symptoms.

• Have taken certain drugs within 30 days prior to study entry including chemotherapy and interferon.

• Are taking acetaminophen or drugs containing acetaminophen.

• Are pregnant or breast-feeding.